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A Pivotal Trial to Assess the Safety and Clinical Efficacy of the M-001 as a Standalone Universal Flu Vaccine

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ClinicalTrials.gov Identifier: NCT03450915
Recruitment Status : Not yet recruiting
First Posted : March 1, 2018
Last Update Posted : March 1, 2018
Sponsor:
Information provided by (Responsible Party):
BiondVax Pharmaceuticals ltd.

Brief Summary:
The pivotal Phase 3 trial plans to enroll a total of 9,630 participants aged 50+ over two years. Participants will be immunized twice with the M-001 universal influenza vaccine candidate or placebo and then followed for up to 2 seasons. The trial will evaluate the number of influenza cases in each group and the severity of illness during the follow up period.

Condition or disease Intervention/treatment Phase
Influenza Biological: M-001 Biological: Saline Phase 3

Detailed Description:

The placebo-controlled pivotal clinical efficacy Phase 3 trial plans to enroll a total of 9,630 participants over two years. Participants will be immunized twice with the M-001 influenza vaccine candidate or placebo. Influenza incidence and illness severity will be evaluated throughout the follow-up period of up to two years. Participants will be 50 years and older, with at least half over 65 years of age.

The trial is expected to take place in eastern European countries and begin prior to the 2018/19 Northern Hemisphere flu season.


Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 9630 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Intervention Model Description: Experimental group: 2 immunizations with M-001 Control group: 2 injection of saline (placebo)
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Masking Description: All parties are blinded except for the person who prepares the syringe for injection. The M-001 is cloudy white and its appearance is different from the transparent saline that is used for placebo. The person prepares the syringe with an opaque sticker that fully covers the syringe contents. People administering the syringe are not involved or present during syringe preparation, and are thus fully blinded.
Primary Purpose: Treatment
Official Title: A Pivotal Multi-center, Randomized, Modified Double-blind, Placebo-controlled Phase 3 Trial to Assess the Safety and Clinical Efficacy of M-001 Influenza Vaccine Administered Intra-muscularly Twice in Older Adults and Elderly (≥50 Years).
Estimated Study Start Date : August 2018
Estimated Primary Completion Date : May 2020
Estimated Study Completion Date : December 2020

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Flu Flu Shot

Arm Intervention/treatment
Experimental: M-001
Participants will be vaccinated with 1mg dose of M-001 twice: Once at Day 0, and once at Day 21.
Biological: M-001
A recombinant protein containing 9 conserved epitopes from Influenza A and B that are common to the vast majority of influenza viruses.
Other Name: Multimeric-001

Placebo Comparator: Saline
Participants will be vaccinated with saline twice: Once at Day 0, and once at Day 21.
Biological: Saline
0.9% sodium chloride (NaCl)




Primary Outcome Measures :
  1. Clinical Efficacy: PCR and Culture Confirmed Influenza [ Time Frame: Up to 2 flu seasons (approximately 1.5 years) ]
    If a participant presents with ILI, then we will run Polymerase chain reaction (PCR). If the PCR is positive, then we will culture confirm. Outcome measure is percentage of PCR and culture confirmed influenza cases in the M-001 experimental group vs. placebo caused by any influenza A or B virus in association with Influenza-like illness (ILI) symptoms.

  2. Safety: Occurrence of vaccine-related serious adverse events (SAEs) [ Time Frame: 6 months ]
    Occurrence of vaccine-related serious adverse events (SAEs) such as solicited and unsolicited injection site and systemic reactogenicity events.


Secondary Outcome Measures :
  1. Clinical Efficacy: PCR Confirmed Influenza [ Time Frame: Up to 2 flu seasons (approximately 1.5 years) ]
    Percentage of PCR confirmed influenza cases in the M-001 experimental group vs. placebo

  2. Lot consistency [ Time Frame: 42 days ]
    Frequency of T-cell subsets from participants in the experimental group, expressing interferon gamma (IFN-g) in cluster of differentiation 4 (CD4+) peripheral blood mononuclear cells (PBMCs) after stimulation with M-001 16 days after the second dose of M-001 as compared to baseline.


Other Outcome Measures:
  1. Reduced severity of illness [ Time Frame: Up to 2 flu seasons (approximately 1.5 years) ]
    Average time to alleviation of each influenza symptom



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Ages Eligible for Study:   50 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:

  1. Male and female subjects 50 years of age (inclusive) or older, mentally competent, willing and able to give the written informed consent prior to study entry
  2. Able to comply with the trial procedures and be available for all study visits.
  3. Medically stable. (Subjects may have underlying chronic conditions such as hypertension, diabetes, ischemic heart disease, or hypothyroidism, as long as their symptoms/signs are controlled. If they are on medication for a condition, the medication dose must have been stable for at least 3 months preceding vaccination).
  4. Women of childbearing potential (not surgically sterile or postmenopausal for greater than or equal to one year) and men must agree to practice adequate contraception (barrier or hormone methods or intra uterine device (IUD) for women and a condom for men) throughout the study treatment and for at least up to day 51 (for female) and day 111 (for male) of the trial (i.e. 30 (for female) and 90 (for male) days after the last dose of the IMP)
  5. Female subjects of childbearing potential must have a negative urine or serum pregnancy test within 24 hours prior to study vaccination.

Exclusion Criteria:

  1. History of neurological symptoms or signs, or anaphylactic shock following administration of any vaccine.
  2. Known or suspected (or have a high risk of developing) impairment/alteration of immune function (excluding that normally associated with advanced age).
  3. Receipt of: a) Immunosuppressive drugs: i) systemic glucocorticoids >/= 10 mg prednisone per day ii) cytotoxic drugs b) Investigational drugs within 30 days before, or planned during, the study c) Blood products within 3 months before, or planned during, the study d) Influenza vaccine within 6 months before the study) Other vaccines within 30 days before, or planned during, the study
  4. Any serious disease such as: cancer, autoimmune disease, advanced arteriosclerotic disease or complicated diabetes mellitus, chronic obstructive pulmonary disease (COPD) that requires oxygen therapy, acute or progressive hepatic disease, acute or progressive renal disease, or congestive heart failure, as judged by the PI.
  5. An acute illness, including an axillary temperature greater than 38 Celsius (38ºC), occurred within 1 week before first vaccination
  6. Positive positive urine pregnancy test prior to vaccination or women who are breastfeeding.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03450915


Contacts
Contact: Tamar Ben-Yedidia, PhD +97289302529 benyedidia@biondvax.com

Sponsors and Collaborators
BiondVax Pharmaceuticals ltd.
Investigators
Study Director: Tamar Ben-Yedidia, PhD BiondVax Pharmaceuticals ltd.

Responsible Party: BiondVax Pharmaceuticals ltd.
ClinicalTrials.gov Identifier: NCT03450915     History of Changes
Other Study ID Numbers: BVX-010
First Posted: March 1, 2018    Key Record Dates
Last Update Posted: March 1, 2018
Last Verified: February 2018
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No

Keywords provided by BiondVax Pharmaceuticals ltd.:
Influenza
vaccine
universal
M-001
Multimeric-001
Flu

Additional relevant MeSH terms:
Influenza, Human
Orthomyxoviridae Infections
RNA Virus Infections
Virus Diseases
Respiratory Tract Infections
Respiratory Tract Diseases
Vaccines
Immunologic Factors
Physiological Effects of Drugs